DRUG DESCRIPTION

VASOVIST (gadofosveset trisodium) Injection is a sterile,
nonpyrogenic, formulation of a stable gadolinium diethylenetriaminepentaacetic
acid (GdDTPA) chelate derivative with a diphenylcyclohexylphosphate group. Each
mL of VASOVIST Injection contains 244 mg of gadofosveset trisodium (0.25 mmol),
0.27 mg of fosveset, and water for injection.

It contains no preservative and the solution pH ranges
between 6.5 to 8.0.

Gadofosveset trisodium is chemically
trisodium-{(2-(R)-[(4,4-diphenylcyclohexyl)
phosphonooxymethyl]-diethylenetriaminepentaacetato)(aquo) gadolinium(III),with
a molecular weight of 975.88 g/mol, and an empirical formula of C33H40GdN3Na3O15P.
It has a structural formula:

Vasovist Patient Information Including Side Effects

Brand Names: Vasovist

What are the possible side effects of gadofosveset trisodium (Vasovist)?

What is the most important information I should know about gadofosveset trisodium (Vasovist)?

What should I discuss with my health care provider before receiving gadofosveset trisodium (Vasovist)?

How is gadofosveset trisodium given (Vasovist)?

What happens if I miss a dose (Vasovist)?

What happens if I overdose (Vasovist)?

What should I avoid after receiving gadofosveset trisodium (Vasovist)?

What other drugs will affect gadofosveset trisodium (Vasovist)?

Where can I get more information?

What is gadofosveset trisodium (Vasovist)?

Gadofosveset trisodium is a contrast agent. Gadofosveset trisodium produces magnetic effects. It is used in combination with magnetic resonance angiography (MRA) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRA.

Gadofosveset trisodium is used to help diagnose certain disorders of the heart and blood vessels.

Gadofosveset trisodium may also be used for other purposes not listed in this medication guide.

What are the possible side effects of gadofosveset trisodium (Vasovist)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

urinating more or less than usual, or not at all;

feeling light-headed, fainting;

skin changes where the injection was given; or

fast, uneven heart rate.

Less serious side effects may include:

mild itching;

headache, dizziness;

nausea, unusual or unpleasant taste in your mouth;

warmth, redness, burning, or tingly feeling under your skin;

cold feeling, warmth, pain, bruising, or burning where the injection was given; or

numbness or tingling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about gadofosveset trisodium (Vasovist)?

Gadofosveset trisodium can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

burning, itching, swelling, and tightening or hardening of your skin;

muscle weakness;

pain or stiffness in your arms, hands, legs, or feet;

deep bone pain in your ribs or your hips;

yellow patches on the whites of your eyes; or

skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease. You may not be able to receive gadofosveset trisodium.

Tell your doctor if you have a heart rhythm disorder, a personal or family history of "Long QT Syndrome," liver disease, asthma or allergies, or if you are on dialysis.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.